A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 65 - 85 |
Updated: | 8/11/2018 |
Start Date: | July 16, 2015 |
End Date: | March 23, 2020 |
A Phase 2, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 To 85 Years
This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85
years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination
schedules. The study will assess the safety and tolerability of the vaccine as well as the
subjects' immune response to the vaccine. One year after the third dose subjects that did not
receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up
to 4 years after their third vaccination.
years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination
schedules. The study will assess the safety and tolerability of the vaccine as well as the
subjects' immune response to the vaccine. One year after the third dose subjects that did not
receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up
to 4 years after their third vaccination.
Inclusion Criteria:
- Healthy male and female subjects
- Aged 65 to 85 years
Additional Inclusion Criteria for the extension Stage:
- Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in
the original portion of the study.
Exclusion Criteria:
- Proven or suspected prior episode of Clostridium difficile associated diarrhea
- Unstable chronic medical condition
- Disease requiring significant change in therapy or hospitalization for worsening
disease within 8 weeks before receipt of study vaccine
- Serious chronic disorders
- Congenital or acquired immunodeficiency disorders
- Rheumatologic disorders or other illnesses requiring chronic treatment with known
immunosuppressant medications.
- Active or treated leukemia or lymphoma or bone marrow disorder
- Any contraindication to vaccination or vaccine components including previous
anaphylactic reaction to any vaccine or vaccine-related components
Additional Exclusion Criteria for the Extension Stage:
- Subjects originally randomized to placebo during the original portion of the study.
- Subjects who have already completed Visit 9 prior to study unblinding.
We found this trial at
16
sites
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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